STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the...

6
POWER TO TRANSFORM OUTCOMES™ STIMULAN ® Uniquely engineered for the precision and control you demand every time

Transcript of STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the...

Page 1: STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare

P OW E R TO T R A N S FO R M O U TC O M ES ™

ST IMULAN®

Uniquely engineered

for the precision and control you

demand every time

Page 2: STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare

Control and performance at your fingertips S T I M U L A N is a truly absorbable calcium sulfate precision engineered with your demands at the forefront.

a Approved for placement at an infected site1

a No hydroxyapatite, insoluble impurities or PMMA debris

• Does not cause third body damage2-4

• Does not prevent use in articulating surfaces2-4

• Does not act as a nidus for infection5-10

Page 3: STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare

S T I M U L A N®

Uniform starting point created to eliminate inconsistency

S T I M U L A NThe highest level of consistency

and performance

Competitor calcium sulfates

? S T I M U L A N starts with pharmaceutical

grade precursors

Dehydrated to a foundational dry phase

Rehydrated and rebuilt through

recrystallization

Pure phase with highly controlled structure

Proprietary treatment to form unique properties

Where others stop, we are just getting started

Consistency is hard earned and uniquely achieved There is no shortcut to perfection. Which is why we go the extra mile to bring you the exceptional performance characteristics of S T I M U L A N – all made possible through our proprietary DRy26TM methodology. Each and every synthesis of S T I M U L A N undergoes a 26 step process that starts with pharmaceutical grade precursors and takes over 6 weeks to reach maturity.

Our unique DRy26TM recrystallization method dehydrates then rehydrates to precisely restructure the calcium sulfate. This ensures a uniform starting point from which the material is rebuilt under strictly controlled conditions for the highest level of consistency.

The result is as you would expect from the world’s leading expert in innovative calcium technologies.

Page 4: STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare

Case-by-case flexibility and success Every part of S T I M U L A N has been designed to provide simplicity, intra-operative flexibility and optimum results. A variety of formats are available, all convenient to prepare and fast to set.

Unrivaled evidence and expertise brings confidence

With our industry-leading knowledge, dedication and experience, you can be sure that the high level of consistency you demand in your cases will be met.

Peer reviewed papers, presentations and posters to date

All

Infection related

Multiple patient

Pathogen specific

282

43

124

292

127

234

Used in over 30,000 cases

every year

44

6 mm 4.8 mm

9 mm

3 mm

7 mm

Beads

Paste

Bullets

Support as reliable as our outcomes

To ensure that you achieve the consistent results you expect, our comprehensive network of regional calcium sulfate specialists, expert sales representatives and surgeons already using S T I M U L A N are ready to support your use.

Page 5: STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare

Properties that drive performance The unique crystal configuration and construction of S T I M U L A N brings its own set of qualities to fully support your infected cases.11

• Easily mixed with liquid, powder and heat-sensitive antibiotics12

• Physiological pH

• Controlled purity (no insoluble impurities)

• No hydroxyapatite

• Hydrophilic

See the S T I M U L A N difference in your cases

a Truly absorbable5-10

a Optimal absorption profile5-10

a Predictable elution profile13-14

a Reliable setting time12

a Physiological compatibility with the body5,10,12

a No third body damage2-4

a Low levels of drainage15

Page 6: STIMULAN - biocomposites.com · STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare

S T I M U L A N®

Find out more at biocomposites.com

When you need it – S T I M U L A N delivers every timea Approved for placement at an

infected site1

a Uniquely engineered through our DRy26™ recrystallization method11

a Optimal absorption profile5-10

a May be mixed with antibiotics1

a Predictable elution profile13-14

a No hydroxyapatite, insoluble impurities or PMMA debris5-10

a Does not cause third body damage2-4

a Does not prevent use in articulating surfaces2-4

a Does not act as a nidus for infection5-10

a Low levels of drainage15

References: 1. Biocomposites, STIMULAN Instructions for Use. 2. Cowie, R.M., et al., Influence of third-body particles originating from bone void fillers on the wear of ultra-high-molecular-weight polyethylene. Proc Inst Mech Eng H, 2016. 230(8): p. 775-83. 3. Cowie, R.M., et al., The Influence of Third Body Damage by a Calcium Sulfate Bone Void Filler on the Wear of Total Knee Replacements., in Orthopaedic Research Society Annual Meeting. 2016: Orlando, FL. p. 103. 4. Lewicki, K., et al., The Effect of Absorbable Calcium Sulfate on Wear Rates in Ultra-high-Molecular-weight Polyethylene: Potential Implications for Its Use in Treating Arthroplasty Infections. J Am Acad Orthop Surg, 2017. 5. Somasundaram, K., et al., Proximal humeral fractures: the role of calcium sulphate augmentation and extended deltoid splitting approach in internal fixation using locking plates. Injury, 2013. 44(4): p. 481-7. 6. Lei, D., et al., Treatment of Distal Radius Bone Defects with Injectable Calcium Sulphate Cement., in Bone Grafting, A. Zorzi, Editor. 2012, InTech. p. 125-134. 7. Lei, D., L. Jing, and S. Yang-yong, Calcium sulfate versus calcium phosphate in treating traumatic fractures. JOURNAL OF CLINICAL REHABILITATIVE TISSUE ENGINEERING RESEARCH., 2008. 12. 8. Lei, D., Z. Ma, and X. Jing, Treatment of bone defect with injectable calcium sulfate powder in distal fractures of radius. Chinese Journal of Bone Tumor and Bone Disease, 2007. 9. Aiken, S.S., J.J. Cooper, and S. Zhou, Osseointegration of a calcium sulphate bone substitute in a large animal model, in The 5th International Congress of Chinese Orthopaedic Association. 2010: Chengdu, China. 10. Lazarou, S.A., G.B. Contodimos, and I.D. Gkegkes, Correction of alveolar cleft with calcium-based bone substitutes. J Craniofac Surg, 2011. 22(3): p. 854-7. 11. Cooper, J.J., Method of producing surgical grade calcium sulphate; Patent. 1999. 12. Biocomposites, Data on file. 13. Aiken, S.S., et al., Local Release of Antibiotics for Surgical Site Infection Management Using High-Purity Calcium Sulfate: An In Vitro Elution Study. Surg Infect (Larchmt), 2014. 14. Gauland, C., The use of antibiotic impregnated, implanted synthetic calcium sulphate tablets in the treatment of soft tissue, vancomycin resistant, enterococcus infections, in The Symposium on Advanced Wound Care and Wound Healing Society Annual Meeting. 2011: Gaylord Texan Hotel &Convention Center, Dallas, Texas. 15. McPherson, E.J., Dissolvable Antibiotic Beads in Treatment of Periprosthetic Joint Infection. The Use of Synthetic Pure Calcium Sulfate (Stimulan®) Impregnated with Vancomycin & Tobramycin, in 2nd Annual Oxford Bone Infection Conference (OBIC). 2012: Oxford, UK.

For indications, contraindications, warnings and precautions see Instructions for Use. The treating physician is responsible for deciding the type and quantity of antibiotic used. Concurrent use of locally administered antibiotics may affect setting time. The mixing of antibiotics with the STIMULAN Kit / STIMULAN Rapid Cure device is considered off-label usage of the medicinal product. To do so is at the professional risk of the surgeon / healthcare professional. This brochure may include the use of STIMULAN or techniques that go beyond the current clearance / approval granted by the relevant regulatory authority. Please contact your local representative for further information.©2018, Biocomposites, STIMULAN, Bringing Calcium to Life, Power to Transform Outcomes and DRy26 are trademarks / registered trademarks of Biocomposites Ltd. All rights reserved. No unauthorized copying, reproduction, distributing or republication is allowed unless prior written permission is granted by the owner, Biocomposites Ltd.Patents granted: GB2367552, EP 1204599 B1, US 6780391, EP 2594231 B1, US 8883063, CN ZL201210466117.X, GB2496710, EP 3058899 B1Patents pending: GB1502655.2, US 15/040075, CN 201610089710.5, US 15/288328, GB1704688.9, EP 18275044.8, US 15/933936

MA0250R1